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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

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Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

In an abrupt about-face, two of the most prominent pharmaceutical industry associations, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA), have announced a new set of "joint principles" meant to advance clinical data transparency throughout the pharmaceutical industry.

Background

In recent years, a growing number of voices have been clamoring for greater transparency of clinical trials results, largely after some companies were found to have hidden unfavorable data regarding the safety of drugs which were later recalled.

In the US, these efforts have seen limited success thanks to legislation passed to require basic trials data to be published to ClinicalTrials.gov, as well as lawsuits against companies that have resulted in some formerly-secret trials results released. Despite the success of the website, however, the top-line results of many trials are still never made public.

However, the EU-and in particular the European Medicines Agency (EMA)-is now forging ahead with an ambitious new proposal that would require much more in-depth clinical trials reporting for all trials, regardless of the approval of the drug.

PhRMA and EFPIA have both been seen as being against the EU proposal, and documents leaked earlier in the week revealed that the organizations were plotting to lobby patient groups to oppose it, leading to significant (and negative) coverage in the media.

Similar to a plan released by GlaxoSmithKline in October 2012, the principles permit "qualified scientific and medical researchers" to access patient- and study-level clinical trial data and protocols "as necessary for conducting legitimate research."

While hypothetically opening up data to a wide range of researchers, the exact interpretation of the terms "qualified" and "legitimate" seem open to varying levels of interpretation depending on the company implementing the policy. The proposal goes on to note that each company will be charged with establishing a scientific review board composed of staff not employed by the company, and companies will "publicly post their data request review process and the identity of the external scientists and healthcare professionals who participate in the scientific review board, including any existing relationships with external board members."

In a call with reporters, PhRMA President John Castellani said he did not anticipate issues with the definition of terms, explaining that the principles of the plan and the requirement to disclose any rejected requests would eliminate any questionable behavior.

As with a GlaxoSmithKline proposal, identifying information will be anonymized on the patient level, PhRMA and EFPIA said.

Patients to Benefit

One of the biggest concessions may well be a commitment to share trial results with patients who participate in the trials. Some transparency advocates, including the AllTrials campaign, have argued that patients should not participate in trials if they do not have the expectation that the results will be published, and the PhRMA/EFPIA proposal seems geared toward minimizing the effect of this argument.

Those results will only be a top-line factual summary of data results, but the plan calls for companies to work with US and EU regulators to generate agreed-upon summaries for patients-something Catellani said they are still working with FDA on. However, "companies will [also] evaluate requests for full study reports, including patient-level and study-level data, and share them," the document states.

In addition, "All company-sponsored clinical trials should be considered for publication in the scientific literature irrespective of whether the results of the sponsors' clinical trials are positive or negative," the document states. This applies to all Phase III trials "at a minimum," but also to all products that have been discontinued.

Old Data to Stay Hidden

Notably absent from the proposal, the AllTrials campaign said on its website, is old data-"the evidence we use every day," they observed. Other companies, most notably GSK, have committed to the release of their older data consistent with their new principles.

In a conference call with reporters, Castellani said two factors informed the organizations' stance with respect to this decision. The first, he said, was that older trials data might not have the patient consent necessary to allow for public availability. The second, he added, was that many already-approved drugs are already subject to postmarket analysis, reducing the need for disclosure.

Castellani also noted that both EFPIA and PhRMA had obtained commitments from all of their respective member organizations to adhere to the principles of the program. When pressed as to whether either organization would support a law that required the principles, he said such a measure would be "unnecessary."

Companies committed to the principles should do so on a public website, the document says.

Some companies, including pharmaceutical giant Pfizer, have already released statements saying they are "reviewing [its] policies to ensure they fully reflect the new commitments." A statement by Eli Lilly, however, was far more guarded in its explanation of the principles.